David Theine

Background

About David Theine

I am a highly motivated and results-driven Quality and Regulatory Affairs professional with extensive experience across the pharmaceutical industry. With a Bachelor’s in Biochemistry from the University of Wisconsin-Madison and a deep understanding of regulatory frameworks, I have excelled in roles ranging from regulatory affairs to quality management.In my current position as a Quality Manager at PCI, I support a variety of client teams, ensuring that quality goals are met while fostering a culture of continuous improvement, customer service, and safety. I am passionate about empowering team members, supporting cross-functional projects, and navigating complex challenges to deliver exceptional results.Previously, I have held positions as a Regulatory Affairs Specialist and QA Auditor, where I honed my skills in regulatory compliance, CMC submissions, risk assessment, and audit management. I take pride in my ability to balance multiple priorities, meet tight deadlines, and ensure adherence to regulatory standards.As a certified Regulatory Affairs Professional (RAC), I am also a proactive problem solver with a knack for driving efficiency through process improvement. Whether it’s through developing training programs, managing complex audits, or authoring technical documentation, I consistently deliver high-quality work.Let’s connect to discuss how my expertise in quality assurance and regulatory affairs can contribute to your organization’s success.